Randomized Phase III Trial of Surgery Plus Neoadjuvant TS-1 and Cisplatin Compared With Surgery Alone for Type 4 and Large Type 3 Gastric Cancer: Japan Clinical Oncology Group Study (JCOG 0501)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 316
- 试验地点
- 35
- 主要终点
- overall survival
研究概览
简要总结
The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and large type 3 tumor in comparison with surgery alone.
详细描述
A randomized phase III study is going to started in Japan to compare TS-1 plus cisplatin as a neoadjuvant chemotherapy with surgery alone in patient with type 4 and large type 3 gastric cancer.A total of 300 patients will be accrued for this study from 35 institutions within five years. The primary endpoint is overall survival. The secondary endpoints are progression free survival (PFS), response rate, proportion of protocol achievement, proportion of curative resection, and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically proven adenocarcinoma of stomach
- •Borrmann type 4 or large (>=8 cm) type 3
- •no evidence of distant metastasis including liver(M0)
- •no evidence of para-aortic and/or retropancreatic lymph node metastasis(N0-2)
- •no peritoneal metastasis and negative peritoneal lavage cytology (PLS) with laparoscopic confirmation
- •no involvement of the esophagus with > 3cm
- •an age of 20-75 years
- •an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- •no prior chemotherapy, radiotherapy for any malignancy
- •no prior surgery for gastric cancer except for endoscopic membrane resection (EMR)
- •no breeding from primary tumor or gastrointestinal stenosis
- •sufficient oral intake
- •adequate organ function
- •written informed consent
排除标准
- •synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
- •pregnant or breast-feeding women
- •severe mental disease
- •systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
- •other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
- •myocardial infarction within six disease-free months
研究组 & 干预措施
1
Procedure/Surgery: Gastrectomy with more than D2 dissection
干预措施: Gastrectomy with more than D2 dissection (Procedure)
2
Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
干预措施: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy (Drug)
结局指标
主要结局
overall survival
时间窗: during the study conduct
次要结局
- progression free survival (PFS)(during the study conduct)
- response rate(during the study conduct)
- adverse events(during the study conduct)
- proportion of protocol achievement(during the study conduct)
- proportion of curative resection(during the study conduct)
研究者
Haruhiko Fukuda
JCOG Data Center
Japan Clinical Oncology Group